Emory University IRB Reliance Agreement

 Institutional Signoff and Local Context Review Form 
Study Title:

Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse
Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a
Transformational Era (MIC-DROP)

Reviewing IRB PI:
Reviewing IRB
Study ID:

20225896

Emory PI:

Patrick Sullivan

Emory Study ID:

STUDY00005355

Emory IRB Contact: Chelsea Cassara
Email and Phone:

[email protected]

1. Engagement

✔

Emory University does consider the role of its study team engaged in human subjects research. 
Emory University does not consider the role of its study team engaged in human subjects 
research.  Stop here and sign the last page of the form.  

2. Study Team Qualifications and Education

✔

All study team members have completed all of their required training including current training 
in human subjects protection and have the experience and expertise to conduct this research. 
All study team members do not have all of their required training including current training in 
human subjects protection and the necessary experience and expertise to conduct this research
Provide details:  

v6.01.2023 

3.

Investigator Conflicts of Interest

✔

The investigators have not identified any financial interests related to this study. 
The  investigators  have  identified  any  financial  interests  related  to  this  study.  The  COI 
Management Plan has been provided to the study team and is to be submitted to the
reviewing IRB with this form.  

4. Site‐Specific Informed Consent Forms
N/A - This site is not enrolling participants.

✔

All necessary site‐specific language has been inserted into the model Informed Consent 
form(s) including contact information, cost, compensation and subject injury language, HIPAA 
authorization, and conflict of interest disclosure, if applicable. Emory embeds HIPAA
Authorization within our site-specific consent form.

5. Recruitment and Informed Consent
The study team is requesting a partial HIPAA waiver for recruitment purposes.

✔

Emory University does not have concerns regarding recruitment procedures and informed 
consent process as described in the protocol.  
Emory University does have concerns regarding recruitment procedures and informed consent 
process as described in the protocol.  
Provide Details:

6. Ancillary Reviews
Upon completion of all ancillary reviews required by Emory University, information was not 
identified that may assist the reviewing IRB in its review of the research.  

✔

Upon completion of all ancillary reviews required by Emory University, information was 
identified that may assist the reviewing IRB in its review of the research. 
Provide Details:
Security Review attached.

7. Local Cultural Concerns

✔

Emory University has not identified any specific ethical concerns pertaining to the community 
from which research participants will be recruited. 
Emory University has identified any specific ethical concerns pertaining to the community 
from which research participants will be recruited. 
Provide Details:

8. State Laws and Institutional Policies

✔

Emory University has not identified state or local laws, regulations, or institutional policies 
relevant to this study. 
Emory University has identified state or local laws, regulations, or institutional policies relevant 
to this study. 
Provide Details: 

Emory Institutional Signoff Language
Dear Study Team,
The Emory IRB has completed its local context review. This form is to be provided to the reviewing
IRB along with the consent forms that the Emory IRB reviewed and the completed External IRB
Consent Checklist. The consent forms are not to be changed once the Emory IRB has issued this
signoff.
Note: If you need a partial HIPAA waiver for recruitment purposes, you will need to request if from
the reviewing IRB when you complete your submission.
Once you receive approval from the reviewing IRB, you are required to upload the approval letter and
approved consent forms in a logged comment in the study history tab. Be sure to also provide them
to the other offices at Emory that need them.
You may now proceed with your submission to the reviewing IRB. Include in your submission to the
reviewing IRB a copy of this form, the site-specific informed consents reviewed by the Emory IRB and
the completed External IRB Consent Checklist (if applicable).
Refer to the Collaborative Research page on the Emory IRB website regarding study team
responsibilities for submitting continuing reviews, modifications, and reportable events when Emory
is relying on an external IRB.
signed by Chelsea Cassara
Chelsea Cassara Digitally
Date: 2023.06.15 11:53:14 -04'00'

    Signature  

Research Protocol Analyst 6/15/2023
   Title  

   Date